FDA Label for Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride
View Indications, Usage & Precautions
Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Walgreens. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
(in each extended-release tablet)
Fexofenadine HCl, USP 60 mg
Pseudoephedrine HCl, USP 120 mg
Purpose
Antihistamine
Nasal Decongestant
Uses
• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:• runny nose• sneezing• itchy, watery eyes• itching of the nose or throat
• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies• reduces swelling of nasal passages• temporarily relieves sinus congestion and pressure• temporarily restores freer breathing through the nose
Warnings
Do Not Use
•
if you have ever had an allergic reaction to this product or any of its ingredients•
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.•
if you have difficulty swallowing
Ask A Doctor Before Use If You Have
• heart disease• thyroid disease• glaucoma• high blood pressure• diabetes• trouble urinating due to an enlarged prostate gland• kidney disease. Your doctor should determine if you need a different dose.
When Using This Product
•
do not take more than directed•
do not take at the same time as aluminum or magnesium antacids•
do not take with fruit juices (see Directions)
Stop Use And Ask Doctor If
•
an allergic reaction to this product occurs. Seek medical help right away.•
symptoms do not improve within 7 days or are accompanied by a fever•
you get nervous, dizzy, or sleepless
If Pregnant Or Breast-Feeding
ask a health professional before use.
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
•
do not divide, crush, chew or dissolve the tablet; swallow tablet whole
adults and children 12 years of age and over | take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours |
children under 12 years of age | do not use |
adults 65 years of age and older | ask a doctor |
consumers with kidney disease | ask a doctor |
Other Information
• do not use if carton is opened or if individual blister units are torn or opened.• store between 20° to 25°C (68° to 77°F)• USP dissolution test is pending.
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, ethyl cellulose, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid.
Questions Or Comments?
call toll free 1-800-818-4555 weekdays
Principal Display Panel
NDC 0363-2110-30
NON-DROWSY
ORIGINAL PRESCRIPTION STRENGTH
Wal-Fex D®
Fexofenadine HCl 60 mg / Antihistamine
Pseudoephedrine HCl 120 mg / Nasal Decongestant
Extended-Release Tablets, USP
Allergy & Congestion
• Nasal and Sinus congestion Due to Colds or Allergies• Sneezing; Runny Nose; Itchy, Watery Eyes and Itchy Nose or Throat Due to Allergies20 EXTENDED RELEASE TABLETS• Nasal and Sinus congestion Due to Colds or Allergies• Sneezing; Runny Nose; Itchy, Watery Eyes and Itchy Nose or Throat Due to Allergies30 EXTENDED RELEASE TABLETS
Compare to Allegra-D® 12 Hour Allergy & Congestion Tablets active ingredients ‡‡
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
NDC 0363-2110-30
NON-DROWSY
ORIGINAL PRESCRIPTION STRENGTH
Wal-Fex D®
Fexofenadine HCl 60 mg / Antihistamine
Pseudoephedrine HCl 120 mg / Nasal Decongestant
Extended-Release Tablets, USP
Allergy & Congestion
Compare to Allegra-D® 12 Hour Allergy & Congestion Tablets active ingredients ‡‡
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
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